Seltorexant for Depression

No longer recruiting at 167 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must be taking: SSRIs, SNRIs

Disqualifiers: Severe renal insufficiency, Cardiovascular, Diabetes, Suicidal ideation, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, seltorexant, to determine if it improves depression symptoms in people with major depressive disorder (MDD) who have trouble sleeping and have not found success with current antidepressants like SSRIs or SNRIs. Participants will receive either seltorexant or a placebo, alongside their current antidepressant, to compare results. The trial aims to discover if adding seltorexant makes a significant difference and if it is safe for long-term use. Ideal candidates for the trial include those who have experienced depression without psychotic features for less than two years, are currently on an SSRI or SNRI but still have symptoms, including insomnia, and tolerate their current medication well. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for depression.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, it requires participants to continue taking a stable dose of their current SSRI or SNRI antidepressant.

Is there any evidence suggesting that seltorexant is likely to be safe for humans?

Research has shown that seltorexant has been tested for safety when used with other antidepressants. In one study, patients experienced fewer side effects with seltorexant compared to quetiapine XR, suggesting it might be easier for many people to handle. Another study found that seltorexant significantly improved depression symptoms, offering hope for those dealing with depression and insomnia.

Seltorexant has also been tested as a treatment for insomnia alone, demonstrating safety and effectiveness. These results suggest that seltorexant is generally well-tolerated. It is important to note that this trial is in an advanced stage, indicating that earlier studies have likely shown it to be relatively safe for humans. Always consult a healthcare provider to determine if joining the trial is appropriate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Seltorexant is unique because it targets the orexin system, which plays a key role in regulating mood, sleep, and wakefulness. Unlike standard antidepressants, which often work by altering serotonin or norepinephrine levels in the brain, seltorexant offers a novel approach by focusing on orexin receptors. Researchers are excited about this treatment because it has the potential to improve symptoms of depression more rapidly and with fewer side effects than traditional options. This new mechanism of action could open up fresh possibilities for patients who haven't found relief with existing medications.

What evidence suggests that seltorexant could be an effective treatment for major depressive disorder with insomnia symptoms?

In this trial, participants will receive either seltorexant or a placebo. Research has shown that seltorexant, when combined with an antidepressant, can significantly improve depression symptoms in people with major depressive disorder who also have trouble sleeping. One study found that people taking seltorexant had much better depression scores than those taking a placebo. Another study showed that just ten days of seltorexant treatment led to a significant reduction in key depression symptoms. Seltorexant works by blocking orexin-2, a brain chemical that can affect sleep and mood. Early evidence suggests it helps people with both depression and insomnia feel better. ^{1 2 4 6 7}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

Adults with major depressive disorder and insomnia who haven't improved enough on SSRIs or SNRIs can join. They must have a BMI of 18-40, stable health, no severe mental disorders like bipolar or psychosis, no serious sleep disorders other than insomnia, and not be at high risk for suicide.

Inclusion Criteria

I've tried 1-2 antidepressants for my current depression episode without enough improvement.

I've been taking a specific antidepressant without issues for 6 weeks to 18 months.

Your body mass index (BMI) falls within the range of 18 to 40 kilograms per square meter (kg/m^2).

Exclusion Criteria

I have a significant sleep disorder, but not insomnia.

You have had a serious problem with using drugs or alcohol in the past 6 months.

I do not have severe kidney issues or uncontrolled health problems including diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Double-blind Treatment

Participants receive either seltorexant or placebo as adjunctive therapy to antidepressants

6 weeks

Weekly visits

Open-label Treatment

Eligible participants receive seltorexant daily to assess long-term safety and tolerability

1 year

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Seltorexant

Trial Overview The trial is testing Seltorexant as an add-on to antidepressants against a placebo in people whose depression-related insomnia hasn't improved much with current treatments. It also looks at the long-term safety of Seltorexant.

How Is the Trial Designed?

Group I: Seltorexant Experimental Treatment 1 Intervention

Participants will receive seltorexant tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase. Eligible participants who will enter the open label (OL) treatment phase will receive seltorexant tablet daily from OL baseline until the end of phase/ early withdrawal (EW) visit (Up to 1 Year).

Group II: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo tablet orally once daily, from Day 1 to Day 42 in double blind (DB) treatment phase.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. jnj.com jnj.com/media-center/press-releases/johnson-johnsons-investigational-seltorexant-shows-numerically-higher-response-in-patients-with-depression-with-insomnia-symptoms-with-fewer-side-effects-compared-to-quetiapine-xr

Seltorexant, in combination with an oral antidepressant ... Seltorexant and quetiapine XR showed large and clinically meaningful improvements in depressive symptoms (-23.0 and -22.7, respectively), as ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31481683/

The selective orexin-2 antagonist seltorexant (JNJ- ... Ten days of treatment with seltorexant (and not diphenhydramine) resulted in a significant improvement of core depressive symptoms compared to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03227224

NCT03227224 | A Study to Evaluate the Efficacy and ... The study will investigate the antidepressant effects of a range of doses of JNJ-42847922 (seltorexant) (versus placebo), as adjunctive treatment to ...

4. nature.com nature.com/articles/s41380-024-02846-5

Treatment effect and safety of seltorexant as monotherapy ... The improvement in depression severity at week 6 for seltorexant 20 mg was greater in patients with moderate-severe insomnia at baseline, ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39791866/

Seltorexant for major depressive disorder Early clinical evidence suggests that seltorexant is effective in treating MDD, both in individuals diagnosed with insomnia and those not.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12351464/

Efficacy and Safety of Seltorexant in Insomnia Disorder This randomized clinical trial evaluates the safety and efficacy of seltorexant in insomnia disorder.

7. jnjmedicalconnect.com jnjmedicalconnect.com/media/attestation/congresses/neuroscience/2024/ascp/seltorexant-adjunctive-to-antidepressants-in-adults-with-mdd-with-insomnia-symptoms-results-of-a-dou.pdf

Seltorexant, adjunctive to antidepressants, in adults with ... Seltorexant demonstrated statistically and clinically significant improvement in depression, as well as insomnia symptoms, in. MDD participants experiencing an ...